MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 LCS HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Catalog Number 950501219

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The rep was called the day after a tkr procedure to be told the femoral notch impactor had broken.The scrub nurse said it felt a little loose during surgery but after surgery during decontamination the entire plastic part of the instrument came away from the metal.1 x 950501219; lcs hp fem notch impactor; lot no: pg0109- available.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).The device was reviewed by depuy engineering melbourne in a-2937813 which states my assessment is that this complaint is due to wear and tear.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS HP FEM NOTCH IMPACTOR
• Type of Device: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8975488
• MDR Text Key: 156927011
• Report Number: 1818910-2019-103556
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295225263
• UDI-Public: 10603295225263
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 950501219
• Device Lot Number: PG0109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1